US20040054390A1 - Method and device for supporting or strengthening a portion of a lead - Google Patents

Method and device for supporting or strengthening a portion of a lead Download PDF

Info

Publication number
US20040054390A1
US20040054390A1 US10243625 US24362502A US2004054390A1 US 20040054390 A1 US20040054390 A1 US 20040054390A1 US 10243625 US10243625 US 10243625 US 24362502 A US24362502 A US 24362502A US 2004054390 A1 US2004054390 A1 US 2004054390A1
Authority
US
Grant status
Application
Patent type
Prior art keywords
lead
support
portion
lead assembly
coil
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
US10243625
Other versions
US7486994B2 (en )
Inventor
Paul Zarembo
Gregory Ley
Brian Soltis
Daniel Cox
Brett Cryer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardiac Pacemakers Inc
Original Assignee
Cardiac Pacemakers Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems

Abstract

A lead assembly and method of forming a lead assembly is provided. Devices and methods of forming the lead assembly include a support coil. The support coil provides enhanced support and protection from lead damage and failure. A lead assembly and method of forming a lead assembly is also provided including at least one electrode. Electrodes may be incorporated into the support coil design. The lead assembly and method of forming a lead assembly may be incorporated with other medical devices such as an implantable defibrillator.

Description

    FIELD OF THE INVENTION
  • The present invention concerns implantable medical devices, such as defibrillators and cardioverters, and more specifically a lead for an implantable medical device. [0001]
  • BACKGROUND
  • Implantable defibrillators detect the onset of abnormal heart rhythms and apply corrective electrical therapy, specifically one or more bursts of electric current to the heart. A defibrillator assembly includes a set of electrical leads, which extend from a pulse generator housing into the heart. Within the pulse generator housing are a battery for supplying power, monitoring circuitry for detecting abnormal heart rhythms, and a capacitor for delivering the bursts of electric current through the leads to the heart. Since the pulse generator portion of the defibrillator assembly is usually implanted in the left region of the chest or in the abdomen, the leads must extend from that area through veins and into the heart. [0002]
  • During normal daily activity of a patient, the leads must flex through a large number of cycles and withstand various other stresses. Numerous cycles of flexing causes fatigue damage and failure in leads, and other stresses such as axial stress can further cause lead damage. Leads are particularly susceptible to fatigue damage or failure at stress concentration points along the lead. Examples of stress concentration points include, but are not limited to where a lead exits a pulse generator, or where a lead is attached to a more rigid structure such as an electrode. Kinking in a flexural direction and crushing in an axial direction may also be problems in stress concentration points. [0003]
  • Leads may need to follow narrow and tortuous paths which may require short electrodes to navigate tight bends, thus creating more stress concentration points. Additionally, the designed size of leads is decreasing with industry pressure to make less invasive products. Smaller leads tend to be more fragile, which further increases the need for more robust lead designs that can withstand numerous flex cycles and axial stresses. [0004]
  • What is needed is a lead that is more robust and resistant to damage or failure from modes such as fatigue failure, axial damage or failure, or other lead stress failure modes. What is also needed is an electrode and lead design that is flexible and adds axial strength while maintaining a small lead diameter. [0005]
  • SUMMARY
  • The above mentioned problems with lead damage and failure are addressed by the present invention and will be understood by reading and studying the following specification. Devices and methods are provided for a more robust lead design. [0006]
  • A lead assembly is shown that includes a lead. The lead includes an electrical conductor and a flexible insulator coupled to the electrical conductor, the flexible insulator electrically isolating a portion of the electrical conductor. The lead assembly also includes a support structure having an inner surface. The inner surface is coupled to the lead at a selected axial location along the lead and providing structural support to the lead. [0007]
  • Other embodiments may include at least one electrical tissue contact surface coupled to the support structure and coupled to the electrical conductor. In other embodiments, a medical device such as an implantable defibrillator is coupled to the lead assembly. [0008]
  • In one embodiment, the lead assembly includes a stent-like support structure having an inner surface. The inner surface is coupled to the lead at a selected axial location along the lead and providing structural support to the lead. [0009]
  • A method of manufacturing a lead assembly is also shown, the method includes forming a lead. Forming the lead includes forming an electrical conductor and coupling a flexible insulator to a portion of the electrical conductor. The method of manufacturing a lead assembly also includes forming a support coil. Forming the support coil includes forming at least one filar; shaping a number of filar turns; and coupling an inner surface of the support coil to the lead at a selected axial location along the lead. [0010]
  • Other embodiments may include coupling at least one electrical tissue contact surface to the support coil and coupling the electrical tissue contact surface to the electrical conductor. In other embodiments, the method includes coupling a medical device such as an implantable defibrillator to the lead assembly. [0011]
  • These and other embodiments, aspects, advantages, and features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art by reference to the following description of the invention and referenced drawings or by practice of the invention. The aspects, advantages, and features of the invention are realized and attained by means of the instrumentalities, procedures, and combinations particularly pointed out in the appended claims.[0012]
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1A shows one embodiment of an implantable defibrillator assembly. [0013]
  • FIG. 1B shows a magnified view of a portion of one embodiment of an implantable defibrillator assembly. [0014]
  • FIG. 2A shows a side view of one embodiment of a support coil. [0015]
  • FIG. 2B shows an end view of one embodiment of a support coil. [0016]
  • FIG. 3 shows a side view of another embodiment of a support coil. [0017]
  • FIG. 4 shows a portion of one embodiment of a lead assembly. [0018]
  • FIG. 5 shows a portion of another embodiment of a lead assembly. [0019]
  • FIG. 6 shows a portion of another embodiment of a lead assembly. [0020]
  • FIG. 7 shows a portion of another embodiment of a lead assembly. [0021]
  • FIG. 8 shows a portion of another embodiment of a lead assembly. [0022]
  • FIG. 9 shows a side view of one embodiment of a support structure. [0023]
  • FIG. 10 shows a side view of one embodiment of a support structure. [0024]
  • FIG. 11 shows a side view of one embodiment of a support structure. [0025]
  • FIG. 12 shows a side view of one embodiment of a support structure. [0026]
  • FIG. 13 shows a side view of one embodiment of a support structure. [0027]
  • FIG. 14 shows a side view of one embodiment of a support structure.[0028]
  • DETAILED DESCRIPTION
  • In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural changes may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents. [0029]
  • In this document, references to coordinates with respect to leads or lead assemblies will refer to axial locations and radial locations. Longitudinal or axial locations are locations along a longitudinal axis of a lead or lead assembly. Radial locations will use the conventional 2-dimensional radial coordinates (r, θ) in a circle that is normal to the longitudinal axis. The term lateral side will refer to surfaces or portions of a surface that is substantially parallel to a longitudinal axis. It should be noted that leads are generally flexible, and do not always lie along a straight line, however, a linear model will be used for ease of discussion. [0030]
  • FIG. 1 shows an implantable defibrillator assembly [0031] 100 according to one embodiment of the invention. The implantable defibrillator assembly 100 includes a pulse generator 110 and a lead assembly 140. Although an implantable defibrillator 100 is used to illustrate embodiments of the invention, the invention is not limited to implantable defibrillators. Other medical devices using a lead assembly 140 are also within the scope of the invention. The pulse generator 110 includes a power source 120 such as a battery, and monitoring circuitry 130. The lead assembly 140 includes a lead 146, with a proximal end 142 and a distal end 144.
  • FIG. 1B shows the proximal end [0032] 142 of the lead 146 in magnified detail where the lead assembly 140 interfaces with the pulse generator 110. The lead assembly 140 includes a support coil 150, shown attached at the proximal end 142 of the lead 146, and attached to the pulse generator 110. In one embodiment, an interface 152 is formed between an inner surface of the support coil 150 and an outer surface of the proximal end 142 of the lead assembly 140. In one embodiment, the interface 152 is continuous across the entire inner surface of the support coil 150. Other embodiments include a non-continuous interface 152, however, sufficient interfacial contact between the support coil 150 and the lead 146 is utilized to provide structural support for the lead 146.
  • Structural support includes, but is not limited to lateral flexural support, and axial support. Lateral flexural support includes support to resist stresses and fatigue resulting from any radial deflection of a portion of the lead [0033] 146 from a longitudinal axis of the lead 146. Axial support includes support to resist stresses such as tensile stress, compressive stress, and sheer stress that may occur as a result of a force being applied to a lead in a direction substantially parallel to the longitudinal axis.
  • FIG. 2A shows one embodiment of a support coil [0034] 200. The support coil 200 includes a radial thickness 236, with an outer coil diameter 206. An inner coil surface 234 is also indicated in FIG. 2B. The support coil 200 includes a coil portion 210 and, in one embodiment, the support coil 200 includes a collar portion 230. In one embodiment, the coil portion 210 and the collar portion 230 are centered around a coil axis 202. In one embodiment, the support coil includes a stent-like support structure. A stent-like support structure includes several possible designs of stent “walls” that are designed to provide axial and flexural support. A stent-like support structure in embodiments of the present invention, however, is not required to expand or contract radially as is functionally required by actual stents.
  • The embodiment shown in FIG. 2A includes a pair of collar portions [0035] 230. One or more collar portions 230 are included in selected embodiments for structure and for bonding integrity with the lead. Multiple collar portions 230 are included on alternate embodiments for additional support or bonding strength. The support coil 200 in one embodiment is attached to a lead using an interference fit. A collar portion 230 adds structural support in interference fit embodiments by providing additional spring force in the radial direction of the lead assembly. In other embodiments, the support coil is attached to a lead using an adhesive. In an adhesive embodiment, the collar portion 230 provides additional surface area for bonding strength.
  • In one embodiment, the collar portion includes a bonding feature [0036] 232. Through-thickness openings or etched features, etc. are included as possible bonding features 232. A circular through hole is shown in FIG. 2A as an example of a bonding feature 232. Other bonding feature shapes include, but are not limited to, oblong holes, slots, angled cut outs, etc. Although two bonding features 232 are shown in the collar portion 230 in FIG. 2A, single bonding features or other numbers of bonding features are also acceptable. The collar portion 230, in one embodiment, includes a slot 238. In one embodiment, the slot 238 also serves as a bonding feature.
  • The bonding features [0037] 232 increase the bonding strength in both an adhesive mechanism and a mechanical mechanism. The bonding features 232 increase a bond interface area, thus increasing adhesive bond strength. Additionally, the bonding features 232 provide mechanical strength. A cured adhesive that has flowed into and around a bonding feature 232 such as a through-thickness opening, must shear or deform in order to fail rather than merely separate at a bond interface.
  • The coil portion [0038] 210 includes one or more filars. In one embodiment, the filars include flat portions with a substantially rectangular cross section. Various other cross sections, such as square, elliptical, and circular cross sections are included in alternate embodiments. Embodiments with a single filar, or various numbers of filars are within the scope of the application. For example, the embodiment shown in FIG. 2A includes four filars, a first filar 212, a second filar 214, a third filar 216, and a fourth filar 218. Each filar includes a radial cross section width 220. The width 220 within each filar, in one option, can be varied along a filar axis 222. The variations in width affect the physical properties of the support coil 200. Another variable in support coil design includes a filar pitch 224. The pitch can also be varied to affect the physical properties of the support coil 200. Another variable in support coil design includes a filar turn 226. A filar turn 226 is defined as a section of a filar that travels around a circumference of the support coil once. A number of filar turns over a given axial length of the coil portion 210 can also be varied to affect the physical properties of the support coil 200.
  • The support coil as described above, provides some flexibility, while also providing a level of structural support such as flexural support and axial support. By tailoring various features of the support coil [0039] 200, as described above, a physical property of the support coil 200, such as stiffness, is adjusted to the structural needs of a location along a lead. Further, by tailoring the features of the support coil as described above, a gradient of axial stiffness and flexural stiffness in selected embodiments is tailored at individual locations along an axial length of the support coil.
  • In one embodiment, the support coil [0040] 200 is etched from a single piece of metal starting material. In other embodiments, the support coil is laser cut. In one embodiment, the support coil is electropolished after laser cutting. In one embodiment, a flat starting material is first etched or laser cut and subsequently formed into a substantially tubular member. In one embodiment, a substantially flat starting material is welded into a substantially tubular member.
  • Possible starting material metals include, but are not limited to NITINOL, stainless steel, MP35N, tantalum, titanium, alloy combinations of the above, etc. Materials other than metal, such as polymers, may also be used as starting materials. In one embodiment, surfaces that will be exposed inside the patient further include a coating of a bio-compatible material. Examples of bio-compatible materials include, but are not limited to, iridium oxide (IROX), platinum, titanium, tantalum, silver, etc. Bio-compatible materials are attached by methods that may include, but are not limited to, ion bombardment, sputtering, electroplating, electroless plating, etc. [0041]
  • FIG. 3 shows another embodiment of a support coil. A support coil [0042] 300 is shown, including a coil portion 310 and a collar portion 330. The support coil 300 includes a number of filars 312 that form the coil portion 310. Also included in the support coil 300 are a number of linking features 314 that join filar turns together. In the embodiment shown in FIG. 3, four filars are included in the coil portion 310, with linking features 314 between different filars. The linking features 314 may also be used to link between turns of a single filar embodiment. The linking features 314 may be formed using various methods. Methods include, but are not limited to integrally etching the linking features 314 with the filars 312, or joining separately formed linking features 314 to filars 312 by adhesive, mechanical, thermal, etc. techniques.
  • The linking features [0043] 314 in one embodiment, serve as additional bonding features as described above. In one embodiment, the linking features modify support coil properties such as lateral coil stiffness and axial coil stiffness of the support coil 300.
  • Embodiments of the support coil described above are attached to a lead at any of a number of axial locations along a lead of a lead to provide added structural support. Using the example illustrated in FIG. 1B, the support coil [0044] 150 is flexible, and provides resilient support for the lead 146 at stress concentration points such as the proximal end 142. The support coil increases resistance to fatigue damage or failure, and increases resistance to axial damage or failure by providing added structural support to the lead.
  • In a further embodiment, the support coil is integrated with other lead components such as an electrode. The area of a lead around a rigid component such as an electrode is subjected to increased fatigue, axial stresses, and/or bonding stress in the rigid component area. These rigid component areas therefore benefit from embodiments of the present invention. [0045]
  • FIG. 4 shows a lead assembly [0046] 400 including a lead 410. The lead 410, in one embodiment, includes a conductor 412 (shown in schematic form) and an insulator 414 for selectively isolating the conductor 412. A support coil 420 is shown coupled to the lead 410. In one embodiment, the support coil 420 is structurally and electrically attached to the conductor 412 of the lead 410. In another embodiment, the support coil 420 is structurally attached to the insulator 414, with an electrode 422 separately coupled to, or in electrical communication with the conductor 412.
  • The electrode [0047] 422 of the support coil 420 includes a tissue contact surface 424. In one embodiment, the electrode 422 is centered axially on the support coil 420. Other axial locations along the support coil are also included within the scope of the application. The electrode 422 in one embodiment is integrally formed with the support coil 420. In one embodiment, the support coil 420 including the electrode 422 are etched from a single piece of metal starting material. Possible metals include, but are not limited to NITINOL, stainless steel, MP35N, tantalum, titanium, alloy combinations of the above, etc. Materials other than metal, such as polymers, may also be used as starting materials. In one embodiment, the tissue contact surface 424 further includes a bio-compatible material. Examples of bio-compatible materials include, but are not limited to, iridium oxide (IROX), platinum, titanium, tantalum, silver, etc. The bio-compatible material is attached by a method that may include, but is not limited to, ion bombardment, sputtering, electroplating, electroless plating, etc.
  • In one embodiment, the support coil [0048] 420 is bonded to the lead 410. Bonding features similar to those described above may be used to attach the support coil 420 to the lead 410 in bonded embodiments. Methods other than bonding are also contemplated for attachment of the support coil 420 to the lead 410, such as mechanical attachment.
  • FIG. 5 shows a lead assembly [0049] 500 including a lead 510. The lead includes a conductor group 512 (shown in schematic form), and an insulator 514 for selectively isolating the conductor group 512. The conductor group 512 may include a single conductor, or a number of conductors. A support coil 520 is shown coupled to the lead 510. In the embodiment shown in FIG. 5, a first electrode 522 and a second electrode 524 are coupled to the support coil 520, which is in turn coupled to the lead 510. Although a single support coil is shown in FIG. 5 with a number of electrodes coupled to the support coil 520, a number of support coils may also be used to accommodate the number of electrodes. In one embodiment, the first electrode 522 and the second electrode 524 are coupled to separate, individual conductors within the conductor group 512 of the lead 510.
  • FIG. 6 shows a lead assembly [0050] 600 including a lead 610. The lead may include a conductor 612 (shown in schematic form) and an insulator 614 for selectively isolating the conductor 612. A support coil 620 is shown coupled to the lead 610. An electrode 622 is further coupled to the support coil 620. In the embodiment shown in FIG. 6, the electrode is a separate component that is attached to the support coil. In one separate component embodiment, the electrode is formed from a bio-compatible material, while the support coil is formed from a different material. In some embodiments, attachment of a separate bio-compatible electrode is less expensive to manufacture than coating an electrode. Methods of attachment include, but are not limited to, welding, spot welding, laser welding, thermal fitting, memory metal fitting, staking, swaging, crimping, threading, bonding, etc.
  • FIG. 7 shows another embodiment of a lead assembly [0051] 700 including a lead 710, a support coil 720, a tissue contact surface 724, and an outer isolation layer 730. The lead includes an electrical conductor 712 and an insulator layer 714. In one embodiment, the electrical conductor is formed in a coil shape within the insulator layer 714.
  • The support coil [0052] 720 is coupled to the lead 710 by structural attachment to the insulator layer 714. Examples of structural attachment include, but are not limited to adhesive attachment and mechanical attachment. An electrode region 722 is included on the support coil 720 in a central location of the support coil 720. The tissue contact surface 724 is further coupled to the electrode region 722 of the support coil 720. In one embodiment, the electrode region 722 is integrally formed with the support coil 720, and the tissue contact surface 724 is separately attached. One skilled in the art, with the benefit of the present specification, will understand that other variations of integral forming and separate attachment are possible within the scope of the application.
  • An electrical contact [0053] 716 is included in one embodiment to communicate electrically between the electrical conductor 712 and the tissue contact surface 724. The isolation layer 730 is included in selected embodiments to further isolate the support coil 720 from an environment such as inside the human body. In one embodiment, the isolation layer 730 includes a polymer layer.
  • FIG. 8 shows an embodiment of a lead assembly [0054] 800. A lead 802 is included with a conductor diameter 810, and a conductor axis 812. The lead 802 is formed into a spiral shape with a spiral diameter 820 and a spiral axis 822. Further included on the lead assembly 800 are a first electrode 814, and a second electrode 816. Although two electrodes are shown, a single electrode, or a number of electrodes may also be used. In one embodiment, the electrodes 814 and 816 are coupled to an embodiment of a support coil as described above.
  • In operation, a form such as the spiral shown in FIG. 8 is formed on a distal end of a lead assembly, and used to hold the distal end of the lead assembly in place within a blood vessel, or other location within a patient. Formed leads may also be used to aid in guiding or tracking of the lead during a procedure such as insertion. One skilled in the art, having the benefit of the present disclosure will recognize that electrodes need not be included on embodiments where improved tracking of a lead is desired. In one embodiment, a support structure as described in the present disclosure is utilized to support a formed portion of a lead such as a spiral shape, or other shapes. Although a spiral shape is shown, other embodiments are contemplated where a portion of the lead [0055] 802, such as a distal end, is formed into a bend, or shape that deviates from an axis of the rest of the lead 802. It should be noted that conductor assemblies are designed to be flexible. A shape formed into a portion of the lead 802, such as a distal end should be characterized relative to a normal, unstressed state of the lead 802.
  • FIGS. [0056] 9-14 show support structures that are alternatives to embodiments of support coils as described above. The term support structure is defined to include support coils, but not be limited to coil structures such as filars.
  • FIG. 9 shows a support structure [0057] 900. In one embodiment, the support structure 900 includes at least one collar portion 910. The support structure 900 includes at least one ring member 920 and a number of connecting members 930. The connecting members 930 all provide axial support for a lead assembly. The connecting members 930 also provide flexural support to a lead assembly depending on their location around a circumference of the support structure 900. In one embodiment, the connecting members 930 primarily provide flexural support due to flexing of the connecting members 930. Flexing of the connecting members 930 typically provides a larger possible range of motion in the lead, in contrast to tensile deformation of the connecting members 930. In one embodiment, therefore, connecting members are spaced about the circumference of the support structure 900 to provide connecting members to flex in a number of different possible lead bending directions.
  • FIG. 10 shows a support structure [0058] 1000. In one embodiment, the support structure 1000 includes at least one collar portion 1010. The support structure 1000 includes at least one ring member 1020 and a number of connecting members 1030. In one embodiment, the connecting members 1030 include serpentine structures. The serpentine structures 1030 all provide axial support for a lead assembly. The serpentine structures 1030 also provide flexural support to a lead assembly. In one embodiment, the serpentine structures 1030 provide flexural support in both a flexing mode, and a tensile mode. In the tensile mode, the serpentine structures 1030 extend and contract along their individual long axes 1032.
  • FIG. 11 shows a support structure [0059] 1100. In one embodiment, the support structure 1100 includes at least one collar portion 1110. The support structure 1100 includes at least one ring member 1120 and a number of connecting members 1130. In one embodiment, the connecting members 1130 include individual serpentine bends 1132. The connecting members 1130, as well as the serpentine bends 1132 all provide axial support for a lead assembly. The serpentine bends 1132 also provide flexural support to a lead assembly. In one embodiment, the serpentine bends 1132 provide flexural support in both a flexing mode, and a tensile mode. In the tensile mode, the serpentine bends 1132 extend and contract along individual long axes. A number of serpentine bends 1132 can be varied within each connecting member 1130 to further tailor support properties of the support structure 1100.
  • FIG. 12 shows a support structure [0060] 1200. In one embodiment, the support structure 1200 includes at least one collar portion 1210. The support structure 1200 includes a spiral structure 1220 and a number of connecting members 1230. In one embodiment the spiral structure 1220 includes a serpentine structure. The spiral structure 1220 provides axial support as well as flexural support to a lead assembly. In one embodiment, the serpentine structure provide flexural support in both a flexing mode, and a tensile mode. In the tensile mode, the serpentine structure of the spiral structure 1220 extends and contract along a axial length of the serpentine structure.
  • FIG. 13 shows a support structure [0061] 1300. In one embodiment, the support structure 1300 includes at least one collar portion 1310. The support structure 1300 includes a ring structure 1320 and a number of connecting members 1330. The support structure 1300 further includes a holding device 1340. In one embodiment, the holding device 1340 includes a serpentine structure attached at to itself at its ends to form a ring. The holding device 1340 provides some degree of axial and flexural support to a lead assembly. In one embodiment, the holding device 1340 primarily provides a mechanical bond for an end of the support structure 1300, similar to bonding of a collar portion as described in embodiments above. A serpentine structure, as shown in FIG. 13, provides a “hoop force” along the circumference of the ring shaped holding device 1340. The hoop force grips a lead assembly and holds an end of the support structure 1300 in place. Although one holding device 1340 is shown in FIG. 13, two holding devices 1340 at opposing ends of the support structure 1300 are included in other embodiments. Additional holding devices 1340 may also be included along the longitudinal axis of the support structure 1300.
  • FIG. 14 shows a support structure [0062] 1400. In one embodiment, the support structure 1400 includes at least one collar portion 1410. The support structure 1400 includes a hybrid holding device 1420 and a number of connecting members 1430. In one embodiment, the hybrid holding device 1420 includes a portion of serpentine structure 1422 and a portion of collar structure 1424. In one embodiment, the portion of serpentine structure 1422 is attached to the portion of collar structure 1424 to form a ring shaped hybrid holding device 1420. The portion of collar structure 1424 provides structural rigidity and a good bonding surface, while the portion of serpentine structure 1422 provides a degree of flexibility in the hybrid holding device 1420. In one embodiment, the portion of collar structure 1424 further includes at least one bonding feature 1424 similar to embodiments described above. Although one hybrid holding device 1420 is shown in FIG. 14, two hybrid holding devices 1420 at opposing ends of the support structure 1400 are included in other embodiments. Additional hybrid holding device 1420 may also be included along the longitudinal axis of the support structure 1400.
  • Thus a lead assembly and method of manufacturing a lead assembly is shown that is more robust and resistant to damage or failure from modes such as fatigue failure, axial damage or failure, or other lead stress failure modes. A support structure as described above is used to enhance the lead at selected axial locations of the lead, such as stress concentration locations. As shown above, stress concentration locations include locations where the lead is attached to a more rigid body such as a pulse generator housing or an electrode. [0063]
  • The embodiments of support structures and support coils as described above maintain a degree of flexibility, while spreading out lateral flexing stresses at stress concentration points over a larger axial region. The spreading of the lateral flexing stresses reduces fatigue failure. The stiffness of the lead assembly can be tailored over the axial length of the support structure as described above to further enhance the spreading of lateral flexing stresses. [0064]
  • Additionally, axial stresses are reduced by employing various embodiments of support structures as described above. Local axial stresses at stress concentration points are also spread out over a larger axial region due to an increased interfacial area and stronger bond between the support structure and the lead. The additional axial support reduces axial failures including, but not limited to, bond failures around electrodes. [0065]
  • It is understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. [0066]

Claims (31)

    What is claimed is:
  1. 1. A lead assembly, comprising:
    a lead, including:
    an electrical conductor;
    a flexible insulator coupled to the electrical conductor, the flexible insulator electrically isolating a portion of the electrical conductor; and
    a support structure having an inner surface, the inner surface positioned substantially parallel to the lead at a selected axial location along the lead and providing structural support to the lead.
  2. 2. The lead assembly of claim 1, wherein the support structure includes a support coil, the support coil being comprised of at least one filar having a number of filar turns.
  3. 3. The lead assembly of claim 1, wherein substantially all portions of a circumference of the lead are engaged by at least a portion of the support structure.
  4. 4. The lead assembly of claim 2, wherein the support coil includes multiple filars.
  5. 5. The lead assembly of claim 2, wherein a filar cross sectional dimension is varied along a filar length.
  6. 6. The lead assembly of claim 2, wherein a filar pitch is varied along a length of the support coil.
  7. 7. The lead assembly of claim 1, wherein a longitudinal axis of the support structure falls along a single straight line in an unstressed state.
  8. 8. The lead assembly of claim 1, wherein a portion of a longitudinal axis of the support structure is formed into a spiral.
  9. 9. The lead assembly of claim 2, wherein the support coil further includes a number of linking features between filar turns.
  10. 10. The lead assembly of claim 1, wherein the support structure includes a portion of a collar attached to a portion of the support structure.
  11. 11. The lead assembly of claim 10, wherein the portion of the collar includes a bonding structure.
  12. 12. The lead assembly of claim 1, wherein the support structure material includes a polymer.
  13. 13. The lead assembly of claim 1, further including at least one electrical tissue contact surface coupled to a portion of the support structure and coupled to the electrical conductor.
  14. 14. The lead assembly of claim 13, wherein the electrical tissue contact surface is integrally formed with the support structure.
  15. 15. A lead assembly, comprising:
    a lead, including:
    an electrical conductor;
    a flexible insulator coupled to the electrical conductor, the flexible insulator electrically isolating a portion of the electrical conductor; and
    a stent-like support structure having an inner surface, the inner surface positioned substantially parallel to the lead at a selected axial location along the lead and providing structural support to the lead.
  16. 16. The lead assembly of claim 15, wherein substantially all portions of a circumference of the lead are engaged by at least a portion of the stent-like support structure.
  17. 17. The lead assembly of claim 15, further including at least one electrical tissue contact surface coupled to a portion of the stent-like support structure and coupled to the electrical conductor.
  18. 18. The lead assembly of claim 15, wherein the stent-like support structure is coupled to an outside surface of the flexible insulator.
  19. 19. The lead assembly of claim 15, further including a flexible outer layer coupled over at least a portion of the stent-like support structure.
  20. 20. An implantable defibrillator assembly, comprising:
    a pulse generator, including:
    an electrical supply source;
    a control circuit;
    a lead assembly coupled to the pulse generator, including:
    a lead, including:
    an electrical conductor;
    a flexible insulator coupled to the electrical conductor, the flexible insulator electrically isolating a portion of the electrical conductor; and
    a support coil having an inner surface, the inner surface positioned substantially parallel to the lead at a selected axial location along the lead and providing structural support to the lead.
  21. 21. The implantable defibrillator assembly of claim 20, wherein the support coil is located at an interface between the lead assembly and the pulse generator.
  22. 22. The implantable defibrillator assembly of claim 20, wherein the support coil further includes at least one electrical tissue contact surface coupled to a portion of the support coil and coupled to the electrical conductor.
  23. 23. A method of manufacturing a lead assembly, comprising:
    forming a lead, including:
    forming an electrical conductor;
    coupling a flexible insulator to a portion of the electrical conductor;
    forming a support coil, including:
    forming at least one filar;
    shaping a number of filar turns; and
    positioning an inner surface of the support coil substantially parallel to the lead at a selected axial location along the lead, the support coil providing structural support to the lead.
  24. 24. The method of claim 23, wherein forming at least one filar includes forming multiple filars.
  25. 25. The method of claim 23, wherein shaping the number of filar turns includes etching a substantially tubular starting material.
  26. 26. The method of claim 23, wherein shaping the number of filar turns includes laser machining.
  27. 27. The method of claim 23, wherein positioning the support coil includes bonding the support coil to the lead.
  28. 28. The method of claim 23, further including coupling at least one tissue contact surface to the support coil and to the electrical conductor.
  29. 29. The method of claim 28, further including attaching a biocompatible coating to the electrical tissue contact surface.
  30. 30. The method of claim 29, wherein attaching the biocompatible coating includes electroplating a biocompatible coating.
  31. 31. The method of claim 28, wherein coupling at least one electrical tissue contact surface to the support coil includes integrally forming a support coil with an electrical tissue contact surface.
US10243625 2002-09-13 2002-09-13 Method and device for supporting or strengthening a portion of a lead Active 2024-03-11 US7486994B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US10243625 US7486994B2 (en) 2002-09-13 2002-09-13 Method and device for supporting or strengthening a portion of a lead

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US10243625 US7486994B2 (en) 2002-09-13 2002-09-13 Method and device for supporting or strengthening a portion of a lead
DE2003621468 DE60321468D1 (en) 2002-09-13 2003-09-12 Method and apparatus for support or reinforce a pipe section
PCT/US2003/028729 WO2004024228A1 (en) 2002-09-13 2003-09-12 Method and device for supporting or strengtheing a lead
JP2004536231A JP4527535B2 (en) 2002-09-13 2003-09-12 A method and apparatus for supporting or strengthening a lead wire
EP20030752319 EP1536858B1 (en) 2002-09-13 2003-09-12 Method and device for supporting or strengthening a lead

Publications (2)

Publication Number Publication Date
US20040054390A1 true true US20040054390A1 (en) 2004-03-18
US7486994B2 US7486994B2 (en) 2009-02-03

Family

ID=31991694

Family Applications (1)

Application Number Title Priority Date Filing Date
US10243625 Active 2024-03-11 US7486994B2 (en) 2002-09-13 2002-09-13 Method and device for supporting or strengthening a portion of a lead

Country Status (5)

Country Link
US (1) US7486994B2 (en)
EP (1) EP1536858B1 (en)
JP (1) JP4527535B2 (en)
DE (1) DE60321468D1 (en)
WO (1) WO2004024228A1 (en)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060032657A1 (en) * 2004-08-11 2006-02-16 Cardiac Pacemakers, Inc. Lead assembly with flexible portions and method therefor
US20060259106A1 (en) * 2005-05-12 2006-11-16 Arnholt Devon N Interconnected electrode assembly for a lead connector and method therefor
US20060259105A1 (en) * 2005-05-12 2006-11-16 Cardiac Pacemakers, Inc. Internally interconnected electrode assembly for a lead and method therefor
US20070293925A1 (en) * 2006-06-15 2007-12-20 Cardiac Pacemakers, Inc. Biasing and fixation features on leads
US20100318141A1 (en) * 2009-06-15 2010-12-16 Kallis Technical Services Method and apparatus for detecting imminent structural failure of an electrical lead in an implanted cardiac therapy medical device
US20110004285A1 (en) * 2009-01-02 2011-01-06 Medtronic, Inc. System and method for cardiac lead
US20110004286A1 (en) * 2009-01-02 2011-01-06 Medtronic, Inc. System and method for cardiac lead
US20110159748A1 (en) * 2009-12-30 2011-06-30 Lily Lim Terminal connector assembly for a medical electrical lead
US8204606B2 (en) 2002-12-19 2012-06-19 Cardiac Pacemakers, Inc. Implantable lead for septal placement of pacing electrodes
EP2918308A1 (en) * 2014-03-11 2015-09-16 BIOTRONIK SE & Co. KG Insulation tube for an electrical lead for medical use, and method for producing such a tube
US9427575B2 (en) 2008-04-15 2016-08-30 Medtronic, Inc. Extendable implantable elongated member

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7918376B1 (en) * 2009-03-09 2011-04-05 Cardica, Inc. Articulated surgical instrument
US8096457B1 (en) 2009-05-05 2012-01-17 Cardica, Inc. Articulation mechanisms for surgical instrument
US9289208B1 (en) 2009-05-05 2016-03-22 Cardica, Inc. Articulation insert for surgical instrument
JP5542926B2 (en) * 2009-06-26 2014-07-09 カーディアック ペースメイカーズ, インコーポレイテッド Medical device lead containing conductor assembly of reduced single-wire coil heating by mri with improved torque transmission performance
US8494651B2 (en) 2009-12-30 2013-07-23 Cardiac Pacemakers, Inc. Implantable leads with a conductor coil having two or more sections
US9038880B1 (en) 2011-04-25 2015-05-26 Cardica, Inc. Articulated surgical instrument
US9474527B1 (en) 2011-04-26 2016-10-25 Bryan D. Knodel Surgical instrument with discrete articulation
US9566048B1 (en) 2011-04-26 2017-02-14 Cardica, Inc. Surgical instrument with discrete cammed articulation
US9026213B2 (en) * 2011-08-12 2015-05-05 Cardiac Pacemakers, Inc. Medical device lead with conductor fracture prediction
US9989187B2 (en) * 2013-06-10 2018-06-05 Delavan Inc. Tube strain relievers

Citations (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2101713A (en) * 1936-04-25 1937-12-07 Okonite Co Electric connecter or terminal
US2616684A (en) * 1948-06-22 1952-11-04 Max H Richter Cord spring
US3800068A (en) * 1972-01-10 1974-03-26 Belden Corp Strain relief
US4314095A (en) * 1979-04-30 1982-02-02 Mieczyslaw Mirowski Device and method for making electrical contact
US4632488A (en) * 1984-06-08 1986-12-30 Switchcraft, Inc. Cord strain relief device
US5007435A (en) * 1988-05-25 1991-04-16 Medtronic, Inc. Connector for multiconductor pacing leads
US5170802A (en) * 1991-01-07 1992-12-15 Medtronic, Inc. Implantable electrode for location within a blood vessel
US5423865A (en) * 1992-12-11 1995-06-13 Siemens Elema Ab Electrode system for a defibrillator
US5431683A (en) * 1992-12-11 1995-07-11 Pacesetter Ab Electrode system for a defibrillator
US5439485A (en) * 1993-09-24 1995-08-08 Ventritex, Inc. Flexible defibrillation electrode of improved construction
US5517989A (en) * 1994-04-01 1996-05-21 Cardiometrics, Inc. Guidewire assembly
US5531779A (en) * 1992-10-01 1996-07-02 Cardiac Pacemakers, Inc. Stent-type defibrillation electrode structures
US5713945A (en) * 1996-06-13 1998-02-03 Pacesetter, Inc. Implantable lead modified to reduce tissue ingrowth
US5728149A (en) * 1995-12-20 1998-03-17 Medtronic, Inc. Integral spiral band electrode for transvenous defibrillation leads
US5775331A (en) * 1995-06-07 1998-07-07 Uromed Corporation Apparatus and method for locating a nerve
US5823817A (en) * 1996-10-24 1998-10-20 Hamilton Beach/Proctor-Silex, Inc. Cord guard
US5824031A (en) * 1996-02-28 1998-10-20 Cardio Source Apparatus and method for deflecting a tip of a lead or catheter
US5851226A (en) * 1996-10-22 1998-12-22 Medtronic, Inc. Temporary transvenous endocardial lead
US5954761A (en) * 1997-03-25 1999-09-21 Intermedics Inc. Implantable endocardial lead assembly having a stent
US6078839A (en) * 1998-12-09 2000-06-20 Pacesetter, Inc. Abrasion resistant implantable lead insulation protector
US6094596A (en) * 1998-06-19 2000-07-25 Angeron Corporation Transvenous defibrillation lead system for use in middle cardiac vein
US6161029A (en) * 1999-03-08 2000-12-12 Medtronic, Inc. Apparatus and method for fixing electrodes in a blood vessel
US6192277B1 (en) * 1999-07-06 2001-02-20 Pacesetter, Inc. Implantable device with bevel gear actuation for lead retention and actuation
US6219577B1 (en) * 1998-04-14 2001-04-17 Global Vascular Concepts, Inc. Iontophoresis, electroporation and combination catheters for local drug delivery to arteries and other body tissues
US6264598B1 (en) * 1998-08-06 2001-07-24 Implant Sciences Corporation Palladium coated implant
US6445954B1 (en) * 2000-04-04 2002-09-03 Cardiac Pacemakers, Inc. Pulse generator header lead introducer tool
US20030083724A1 (en) * 2001-10-31 2003-05-01 Mandar Jog Multichannel electrode and methods of using same

Patent Citations (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2101713A (en) * 1936-04-25 1937-12-07 Okonite Co Electric connecter or terminal
US2616684A (en) * 1948-06-22 1952-11-04 Max H Richter Cord spring
US3800068A (en) * 1972-01-10 1974-03-26 Belden Corp Strain relief
US4314095A (en) * 1979-04-30 1982-02-02 Mieczyslaw Mirowski Device and method for making electrical contact
US4632488A (en) * 1984-06-08 1986-12-30 Switchcraft, Inc. Cord strain relief device
US5007435A (en) * 1988-05-25 1991-04-16 Medtronic, Inc. Connector for multiconductor pacing leads
US5170802A (en) * 1991-01-07 1992-12-15 Medtronic, Inc. Implantable electrode for location within a blood vessel
US5531779A (en) * 1992-10-01 1996-07-02 Cardiac Pacemakers, Inc. Stent-type defibrillation electrode structures
US5423865A (en) * 1992-12-11 1995-06-13 Siemens Elema Ab Electrode system for a defibrillator
US5431683A (en) * 1992-12-11 1995-07-11 Pacesetter Ab Electrode system for a defibrillator
US5439485A (en) * 1993-09-24 1995-08-08 Ventritex, Inc. Flexible defibrillation electrode of improved construction
US5517989A (en) * 1994-04-01 1996-05-21 Cardiometrics, Inc. Guidewire assembly
US5775331A (en) * 1995-06-07 1998-07-07 Uromed Corporation Apparatus and method for locating a nerve
US5728149A (en) * 1995-12-20 1998-03-17 Medtronic, Inc. Integral spiral band electrode for transvenous defibrillation leads
US5824031A (en) * 1996-02-28 1998-10-20 Cardio Source Apparatus and method for deflecting a tip of a lead or catheter
US5713945A (en) * 1996-06-13 1998-02-03 Pacesetter, Inc. Implantable lead modified to reduce tissue ingrowth
US5851226A (en) * 1996-10-22 1998-12-22 Medtronic, Inc. Temporary transvenous endocardial lead
US5897584A (en) * 1996-10-22 1999-04-27 Medtronic, Inc. Torque transfer device for temporary transvenous endocardial lead
US5823817A (en) * 1996-10-24 1998-10-20 Hamilton Beach/Proctor-Silex, Inc. Cord guard
US5954761A (en) * 1997-03-25 1999-09-21 Intermedics Inc. Implantable endocardial lead assembly having a stent
US6219577B1 (en) * 1998-04-14 2001-04-17 Global Vascular Concepts, Inc. Iontophoresis, electroporation and combination catheters for local drug delivery to arteries and other body tissues
US6094596A (en) * 1998-06-19 2000-07-25 Angeron Corporation Transvenous defibrillation lead system for use in middle cardiac vein
US6264598B1 (en) * 1998-08-06 2001-07-24 Implant Sciences Corporation Palladium coated implant
US6078839A (en) * 1998-12-09 2000-06-20 Pacesetter, Inc. Abrasion resistant implantable lead insulation protector
US6161029A (en) * 1999-03-08 2000-12-12 Medtronic, Inc. Apparatus and method for fixing electrodes in a blood vessel
US6192277B1 (en) * 1999-07-06 2001-02-20 Pacesetter, Inc. Implantable device with bevel gear actuation for lead retention and actuation
US6445954B1 (en) * 2000-04-04 2002-09-03 Cardiac Pacemakers, Inc. Pulse generator header lead introducer tool
US20030083724A1 (en) * 2001-10-31 2003-05-01 Mandar Jog Multichannel electrode and methods of using same

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8204606B2 (en) 2002-12-19 2012-06-19 Cardiac Pacemakers, Inc. Implantable lead for septal placement of pacing electrodes
US20060032657A1 (en) * 2004-08-11 2006-02-16 Cardiac Pacemakers, Inc. Lead assembly with flexible portions and method therefor
US7238883B2 (en) 2004-08-11 2007-07-03 Cardiac Pacemakers, Inc. Lead assembly with flexible portions and method therefor
US7807925B2 (en) 2004-08-11 2010-10-05 Cardiac Pacemakers, Inc. Lead assembly with flexible portions and method therefor
US7962213B2 (en) * 2005-05-12 2011-06-14 Cardiac Pacemakers, Inc. Interconnected electrode assembly for a lead connector and method therefor
US20060259105A1 (en) * 2005-05-12 2006-11-16 Cardiac Pacemakers, Inc. Internally interconnected electrode assembly for a lead and method therefor
US20110208282A1 (en) * 2005-05-12 2011-08-25 Arnholt Devon N Interconnected electrode assembly for a lead connector and method therefor
US20060259106A1 (en) * 2005-05-12 2006-11-16 Arnholt Devon N Interconnected electrode assembly for a lead connector and method therefor
US8437866B2 (en) 2005-05-12 2013-05-07 Cardiac Pacemakers, Inc. Internally interconnected electrode assembly for a lead and method therefor
US8577463B2 (en) 2005-05-12 2013-11-05 Cardiac Pacemakers, Inc. Interconnected electrode assembly for a lead connector and method therefor
US20110071609A1 (en) * 2006-06-15 2011-03-24 Zarembo Paul E Biasing and fixation features on leads
US7865248B2 (en) * 2006-06-15 2011-01-04 Cardiac Pacemakers, Inc. Biasing and fixation features on leads
US20070293925A1 (en) * 2006-06-15 2007-12-20 Cardiac Pacemakers, Inc. Biasing and fixation features on leads
US9427575B2 (en) 2008-04-15 2016-08-30 Medtronic, Inc. Extendable implantable elongated member
US20110004286A1 (en) * 2009-01-02 2011-01-06 Medtronic, Inc. System and method for cardiac lead
US20110004285A1 (en) * 2009-01-02 2011-01-06 Medtronic, Inc. System and method for cardiac lead
US9833616B2 (en) 2009-01-02 2017-12-05 Medtronic, Inc. System and method for cardiac lead
US8406892B2 (en) * 2009-06-15 2013-03-26 Kallis Technical Services Method and apparatus for detecting imminent structural failure of an electrical lead in an implanted cardiac therapy medical device
US20100318141A1 (en) * 2009-06-15 2010-12-16 Kallis Technical Services Method and apparatus for detecting imminent structural failure of an electrical lead in an implanted cardiac therapy medical device
US8382529B2 (en) 2009-12-30 2013-02-26 Cardiac Pacemakers, Inc. Terminal connector assembly for a medical electrical lead
US8602827B2 (en) 2009-12-30 2013-12-10 Cardiac Pacemakers, Inc. Terminal connector assembly for a medical electrical lead
US9368925B2 (en) 2009-12-30 2016-06-14 Cardiac Pacemakers, Inc. Terminal connector assembly for a medical electrical lead
US20110159748A1 (en) * 2009-12-30 2011-06-30 Lily Lim Terminal connector assembly for a medical electrical lead
EP2918308A1 (en) * 2014-03-11 2015-09-16 BIOTRONIK SE & Co. KG Insulation tube for an electrical lead for medical use, and method for producing such a tube

Also Published As

Publication number Publication date Type
DE60321468D1 (en) 2008-07-17 grant
EP1536858A1 (en) 2005-06-08 application
US7486994B2 (en) 2009-02-03 grant
WO2004024228A1 (en) 2004-03-25 application
EP1536858B1 (en) 2008-06-04 grant
JP4527535B2 (en) 2010-08-18 grant
JP2005538775A (en) 2005-12-22 application

Similar Documents

Publication Publication Date Title
US5545201A (en) Bipolar active fixation lead for sensing and pacing the heart
US7047082B1 (en) Neurostimulating lead
US5800496A (en) Medical electrical lead having a crush resistant lead body
US7860580B2 (en) Active fixation medical electrical lead
US5366496A (en) Subcutaneous shunted coil electrode
US6574512B1 (en) Lead system with main lead and transverse lead
US6438427B1 (en) Dilatable cardiac electrode arrangement for implantation in particular in the coronary sinus of the heart
US6456888B1 (en) Geometry for coupling and electrode to a conductor
US5676694A (en) Medical electrical lead
US7231260B2 (en) Intravascular self-anchoring electrode body with arcuate springs, spring loops, or arms
US7313445B2 (en) Medical lead with flexible distal guidewire extension
US5324321A (en) Medical electrical lead having sigmoidal conductors and non-circular lumens
US20130172879A1 (en) Renal nerve modulation medical devices
US5683444A (en) Composite electrode
US20070106357A1 (en) Intravascular Electronics Carrier Electrode for a Transvascular Tissue Stimulation System
US6813521B2 (en) Medical electrical lead
US7650184B2 (en) Cylindrical multi-contact electrode lead for neural stimulation and method of making same
US5458629A (en) Implantable lead ring electrode and method of making
US5569883A (en) Joint for providing a secure connection between a wound element and a mating part in a body implantable lead assembly and method for making such joint
US20080161774A1 (en) Catheter with embedded components and method of its manufacture
US20050159800A1 (en) Novel implantable lead including sensor
US4711027A (en) Implantable lead construction
US7158837B2 (en) Low profile cardiac leads
US7239923B1 (en) Lead having varying stiffness and method of manufacturing thereof
US20030092303A1 (en) Multifilar conductor for cardiac leads

Legal Events

Date Code Title Description
AS Assignment

Owner name: CARDIAC PACEMAKERS, INC., MINNESOTA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ZAREMBO, PAUL E.;LEY, GREGORY R.;SOLTIS, BRIAN D.;AND OTHERS;REEL/FRAME:013706/0001;SIGNING DATES FROM 20021030 TO 20030120

FPAY Fee payment

Year of fee payment: 4

FPAY Fee payment

Year of fee payment: 8